A Multicenter, Randomized, Double-blind, Parallel-group, Event-driven, Decentralized, Phase IIIb Study Comparing PT027 With PT007 Administered as Needed in Participants 12 Years of Age and Older With Asthma (BATURA)

Status: Completed
Location: See all (61) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a US study comparing the efficacy and safety of BDA MDI \[Budesonide/Albuterol Sulfate (BDA) metered dose inhaler (MDI)\] with AS \[Albuterol Sulfate\] MDI, both are administered as needed for up to 12 months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Participant must be ≥12 years of age, at the time of signing the electronic informed consent form (eICF). For participants from 12 years of age to age of majority, their parents/legal guardian must provide signed consent, as appropriate, and participants will sign an assent form.

• Diagnosis of asthma by a prescribing healthcare professional. Protocol-specified documentation of asthma diagnosis is required to confirm diagnosis of asthma.

• Participants actively using SABA alone or SABA on a background of either low-dose ICS or LTRA.

• Self-reported use of a SABA on ≥2 occasions, in response to symptoms (ie, not for exercise prophylaxis only), in the previous 2 weeks prior to enrollment.

• An Asthma Impairment and Risk Questionnaire (AIRQ) score of ≥2 at Screening (Visit1/re-screen) and Randomisation (Randomization (Visit2) where applicable. Note, where screening Visit1/re-screen and randomization occur on the same day, AIRQ will only be completed once.

• Females of child-bearing potential must have a negative pregnancy test prior to randomization and agree to use an acceptable method of contraception throughout the study.

• Male participants who are in heterosexual relationships must be surgically sterile or agree to use an effective method of contraception (condom) if the female partner does not use contraception from the date the eICF is signed until 2 weeks after their last dose.

Locations
United States
Alabama
Pulmonary Associates of Mobile PC
Mobile
Arizona
One of a Kind Clinical Research Center
Paradise Valley
Fiel Family and Sports Medicine/CCT Research
Tempe
California
Kern Research Inc.
Bakersfield
Science 37
Culver City
Antelope Valley Clinical Trials
Lancaster
Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology
San Diego
Clinical Research of California
Walnut Creek
Colorado
Asthma and Allergy Associates
Colorado Springs
Velocity Clinical Research, Denver
Denver
Florida
Helix Biomedics
Boynton Beach
Allergy and Asthma Diagnostic Treatment Center
Tallahassee
Georgia
Centricity Research
Columbus
Centricity Research
Columbus
Centricity Research
Columbus
Centricity Research
Columbus
Lifeline Primary Care
Lilburn
Javara Inc./Privia Medical Group Georgia, LLC
Savannah
Idaho
Velocity Clinical Research - Boise
Meridian
Indiana
Velocity Clinical Research - Valparaiso
Valparaiso
Louisiana
Velocity Clinical Research
Lafayette
Massachusetts
Genesis Clinical Research and Consulting, LLC
Fall River
Infinity Medical Research
North Dartmouth
Maryland
Javara Inc.
Annapolis
Baltimore Early Phase Clinical Unit (EPCU)
Baltimore
Chesapeake Clinical Research
White Marsh
Minnesota
Mankato Clinic
Mankato
Missouri
Spectrum Clinical Research
Kansas City
North Carolina
Javara Inc.
Charlotte
Javara Inc/Wake Forest Health Network, LLC
Clemmons
Monroe Biomedical Research
Monroe
North Carolina Clinical Research
Raleigh
Wilmington Health (Innovo Research)
Wilmington
Nebraska
Meridian Clinical Research, LLC
Lincoln
Midwest Regional Health Services, LLC/CCT Research
Omaha
New York
Meridian Clinical Research
Endwell
Modern Migraine MD/CTNX
New York
Ohio
Buckeye Health and Research
Columbus
Oregon
Velocity Clinical Resarch - Medford
Medford
Northwest Research Center
Portland
Pennsylvania
Hatboro Medical Associates
Hatboro
Rhode Island
Velocity Clinical Research - Providence
East Greenwich
AAPRI Clinical Research Institute
Warwick
CVS Health
Woonsocket
CVS Health
Woonsocket
CVS Health
Woonsocket
CVS Health
Woonsocket
CVS Health
Woonsocket
CVS Health
Woonsocket
South Carolina
Velocity Clinical Research - Anderson
Anderson
Velocity Clinical Research, Greenville
Greenville
Texas
Velocity Clinical Research, Austin
Cedar Park
Privia Medical Group Gulf Coast
Cypress
CardioVoyage LLC
Denison
Texas Health Care, PLLC d/b/a Privia Medical Group- North Texas
Fort Worth
Allure Health at Mt Olympus Medical Research
Friendswood
LinQ Research, LLC
Pearland
Mt. Olympus Medical Research
Sugar Land
Utah
South Ogden Family Medicine clinic
Ogden
Velocity Clinical Research -Salt Lake City
West Jordan
Virginia
Meridian Clinical Research
Portsmouth
Time Frame
Start Date: 2022-09-02
Completion Date: 2024-08-22
Participants
Target number of participants: 2516
Treatments
Experimental: PT027
Participants will receive Budesonide and Albuterol Sulfate Pressurised Inhalation Suspension 160/180 μg up to a maximum of 12 inhalations to max dose.
Experimental: PT007
Participants will receive Albuterol Sulfate Pressurised Inhalation Suspension 180 μg up to a maximum of 12 inhalations to max dose.
Related Therapeutic Areas
Sponsors
Collaborators: Parexel
Leads: Bond Avillion 2 Development LP

This content was sourced from clinicaltrials.gov

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